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Download the ESMO 2012 Abstract Book - Oxford Journals

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Annals of Oncology<br />

1584P HOME-BASED ZOLEDRONIC ACID (ZOL) INFUSION<br />

THERAPY IN PATIENTS WITH SOLID TUMOURS:<br />

COMPLIANCE AND PATIENT-NURSE SATISFACTION<br />

T. Lebret 1 , J. Mouysset 2 , A. Lortholary 3 , C. El Kouri 3 , L. Bastit 4 , M. Ktiouet 5 ,<br />

K. Slimane 5 , X. Muracciole 6 and S. Guérif 7<br />

1 Urology, Hôpital Foch, Suresnes, FRANCE, 2 Oncology, Polyclinique Parc<br />

Rambot-Provençale, Aix en Provence, FRANCE, 3 Medical Oncology, Ca<strong>the</strong>rine<br />

de Sienne Institute, Nantes, FRANCE, 4 Radiothérapie, Centre de Radiothérapie,<br />

Evreux, FRANCE, 5 Oncology, Novartis Pharmaceuticals, Rueil-Malmaison,<br />

FRANCE, 6 Service de Radio<strong>the</strong>rapie, CHU La Timone APHM Marseille, Marseille,<br />

FRANCE, 7 Radiothérapie, CHU Poitiers, Poitiers, FRANCE<br />

Objective: To explore patient and nurse satisfaction, compliance with practice<br />

guidelines, technical feasibility, and safety of home infusion of <strong>the</strong> bisphosphonate<br />

ZOL.<br />

Methods: This was a prospective longitudinal 1-year survey of home ZOL <strong>the</strong>rapy in<br />

patients with bone metastases secondary to a solid malignancy. Randomly selected<br />

physicians prescribed home ZOL <strong>the</strong>rapy (4 mg Zometa®, 15-min IV infusion, every<br />

3-4 weeks). Three questionnaires were administered at 3 time points: physician<br />

questionnaire, nurse satisfaction and feasibility questionnaire, and patient satisfaction<br />

questionnaire. The main end-points were patient and nurse satisfaction with home<br />

ZOL <strong>the</strong>rapy.<br />

Results: Of <strong>the</strong> 154 physicians who agreed to participate, 87 (56.5%) enrolled 818<br />

patients for whom 788 case report forms were received of which 763 met inclusion<br />

criteria. Overall, 343 nurses (97.5% community) took part. Patient characteristics<br />

were: median age 68 yrs (30-95); male-female ratio 40/60; primary cancer: breast<br />

55.2%, prostate 28.4%, lung 7.2%, o<strong>the</strong>r 9.4%; ECOG-PS 0 or 1: 78.6%. Overall,<br />

90.9% of nurses were ei<strong>the</strong>r highly satisfied or satisfied with how home ZOL <strong>the</strong>rapy<br />

was run; 96.7% found <strong>the</strong> infusion ei<strong>the</strong>r very easy or easy to perform; 97.5% felt that<br />

home <strong>the</strong>rapy promoted a good relationship with patients, and 73% were ei<strong>the</strong>r<br />

highly satisfied or satisfied with <strong>the</strong>ir hospital contacts. Among patients, 95.3% were<br />

ei<strong>the</strong>r very satisfied or satisfied with home ZOL <strong>the</strong>rapy. Causes for satisfaction were<br />

quality of <strong>the</strong> nurse-patient relationship (57.6%) in addition to expected reasons (e.g.<br />

less time travelling/waiting (68.8%), less disruption to daily routine (36.6%)). ZOL<br />

<strong>the</strong>rapy was well tolerated (discontinuation due to adverse events 6.1%; osteonecrosis<br />

of <strong>the</strong> jaw 0.6%, fractures 0.2%). Practitioner compliance with recommendations was<br />

73% for dental hygiene checks at inclusion and 48-56% <strong>the</strong>reafter, 66% for<br />

pre-infusion patient hydration, and often undocumented for calcium/vitamin D<br />

supplementation.<br />

Conclusions: There was a very high level of both patient and nurse satisfaction with<br />

home ZOL <strong>the</strong>rapy. However, improved compliance with practice guidelines should<br />

be encouraged.<br />

Disclosure: T. Lebret: Consulting fees : Amgen, Novartis Advisory board : Amgen,<br />

Novartis Honorarium study Novartis, J. Mouysset: Honorarium study Novartis, A.<br />

Lortholary: Honorarium study Novartis, C. El Kouri: Honorarium study Novartis, L.<br />

Bastit: Honorarium study NovartisM. Ktiouet: Novartis EmployeeK. Slimane:<br />

Novartis Employee, X. Muracciole: Advisory board Novartis Consulting fees<br />

Novartis, S. Guérif: Consulting fees Novartis.<br />

1585P A PROSPECTIVE MONO-INSTITUTIONAL STUDY ON THE<br />

IMPACT OF A SYSTEMATIC PREVENTION PROGRAM ON<br />

THE INCIDENCE AND OUTCOME OF OSTEONECROSIS OF<br />

THE JAW (ONJ) IN PATIENTS (PTS) TREATED WITH<br />

BISPHOSPHONATES (B) FOR BONE METASTASES<br />

N.M. La Verde, A. Bramati, S. Piva, M.C. Dazzani, S. Girelli, A. Moretti, D. Mihali,<br />

M. Dimaiuta, A. Pinto and G. Farina<br />

Oncology, A.O. Fatebenefratelli e Oftalmico, Milan, ITALY<br />

Background: B are commonly used to treat bone metastases in cancer pts, who have<br />

a higher risk of developing ONJ. The elective involvement of <strong>the</strong> jaw can have an<br />

anatomic rationale, since this region has a thin mucosa and microbiological<br />

contamination. The jaw is exposed to dental microtraumatisms and infections, so<br />

reparation mechanisms are essential. B inhibits bone turnover and since <strong>the</strong><br />

increased demand for bone repair isn’t satisfied, <strong>the</strong> bone is exposed to osteonecrosis.<br />

To reduce this risk we have developed a specific prevention program focused<br />

primarily on reducing its incidence and, wherever it develops, <strong>the</strong> need for<br />

demolitive surgery with permanent sequelae.<br />

Patients and methods: All consecutive pts with bone lesions, that were eligible for<br />

treatment with B (ei<strong>the</strong>r zoledronic or pamidronic acid) were prospectively evaluated.<br />

Before starting B, each patient was referred to an specialized odontoiatric team that<br />

performed: 1. dental examination; 2. orthopantomography; 3. professional dental<br />

hygiene. If <strong>the</strong> oral conditions weren’t satisfactory (i.e., tooth decay, dental plaque,<br />

broken teeth), <strong>the</strong> dentist completed <strong>the</strong> necessary intervention before starting B.<br />

Results: From April 2007 to April <strong>2012</strong> we collected data of 254 pts, 243 of which<br />

were treated with zoledronic acid and 9 with pamidronic acid. The median age was<br />

74 years old (range 37-95), 92 male and 162 female. All pts had bone involvement:<br />

74 pts had breast cancer, 39 lung cancer, 36 prostate cancer, 33 multiple myeloma<br />

and 72 o<strong>the</strong>rs. On average <strong>the</strong> pts received 9.7 cycles (range 1-48). No case of ONJ<br />

was recorded.<br />

Conclusions: Our study demonstrates that ONJ can be effectively prevented with a<br />

serious program that involves a multidisciplinary team. The odontoiatric basal<br />

evaluation is necessary to identify pts with oral pathologies or inadequate oral<br />

hygiene who must undergo preventive dental treatment. When reparative<br />

phaenomena are compromised by B, <strong>the</strong> healthy oral environment prevents<br />

infections and subsequent morbidity. In our opinion, this type of preventive program<br />

should be mandatory for all pts starting B.<br />

Disclosure: All authors have declared no conflicts of interest.<br />

1586P QOL AND SURVIVAL SURVEY OF CANCER CACHEXIA IN<br />

ADVANCED NSCLC PATIENTS - JNUQ-LC STUDY, TORG0912<br />

S. Atagi 1 , F. Imamura 2 , A. Yokoyama 3 , K. Minato 4 , T. Harada 5 , N. Katakami 6 ,<br />

T. Yokoyama 7 , Y. Ohashi 8 , K. Watanabe 9 and K. Eguchi 10<br />

1 Department of Thoracic Oncology, Kinki-chuo Chest Medical Center, Osaka,<br />

JAPAN, 2 Department of Thoracic Oncology, Osaka Medical Center for Cancer<br />

and Cardiovascular Diseases, Osaka, JAPAN, 3 Department of Internal Medicine,<br />

Niigata Cancer Center Hospital, Niigata, JAPAN, 4 Department of Respiratory<br />

Medicine, Gunma Prefectural Cancer Center, Ohta, JAPAN, 5 Center for<br />

Respiratory Disease, Hokkaido Social Insurance Hospital, Sapporo, JAPAN,<br />

6 Division of Integrated Oncology, Institute of Biomedical Research and Innovation<br />

Hospital, Kobe, JAPAN, 7 Department of Respiratory Medicine, Kyorin University<br />

Hospital, Tokyo, JAPAN, 8 Department of Biostatistics, School of Public Health,<br />

The University of Tokyo, Tokyo, JAPAN, 9 Department of Respiratory Medicine,<br />

Yokohama Municipal Citizen’s Hospital, Yokohama, JAPAN, 10 Internal Medicine,<br />

Division of Medical Oncology, Teikyo University School of Medicine, Tokyo,<br />

JAPAN<br />

Background: Cancer cachexia, mainly characterized by muscle atrophy and<br />

subsequent cancer induced weight loss (CIWL), is attributed to about a third of<br />

cancer deaths. Despite worsening prognoses with <strong>the</strong> symptoms, clinical factors<br />

involved and <strong>the</strong> effect of CIWL to <strong>the</strong> overall status remain unexplained. We<br />

planned a prospective cohort study, Japan Nutrition and QOL survey in patients<br />

with advanced NSCLC study to investigate changes in CIWL in relation to grip,<br />

QOL, and clinical parameters to understand <strong>the</strong>ir effects on prognosis.<br />

Method: Untreated stage IV NSCLC patients with ECOG PS of 0-2 were registered.<br />

Their body weight (BW), grip, QOL, Karnofsky Performance Scale, biochemical<br />

assay, and survival were recorded every four weeks for one year from <strong>the</strong> start of<br />

cancer treatments. Patients were classified by BW loss ≥ 5% and cachexia diagnosis<br />

by BW loss, fatigue, anorexia, and abnormal assay results. Estimated survival curves<br />

were drawn by Kaplan-Meier method, and Log-rank test was applied. To evaluate <strong>the</strong><br />

effect of cancer cachexia attribution to QOL, we performed principal component<br />

analysis, factor analysis, and analysis on time course data using generalized<br />

estimating equation (GEE).<br />

Results: Out of 466 patients registered, 406 were evaluable and analyzed. Patient<br />

characteristics were: median age: 67 (33-87) years, male/female ratio: 280/126,<br />

median BW: 56.5kg, PS 0: 39.2%, and PS 1: 51.5%. The patients with BW loss of ≥<br />

5% (n = 219) reported more early deaths than those without (n = 166, p < 0.0001).<br />

Patients with cachexia (n = 169) reported more early deaths than those without (n =<br />

216, p < 0.0001). All correlations between principal component scores estimated from<br />

<strong>the</strong> variables considered <strong>the</strong> signs of cancer cachexia (cancer cachexia attributions:<br />

more weight on anorexia, fatigue, BW and grip) and each factor scores of QOL<br />

domains estimated from QOL factor analyses were significant (p < 0.01). From <strong>the</strong><br />

time course data analyses using GEE, cancer cachexia attributions of each visit are<br />

shown as useful variables for all QOL domains (p < 0.01).<br />

Conclusion: Cancer cachexia decreased QOL and possibly affected prognoses.<br />

Cachexia preventions and treatments based on <strong>the</strong> fur<strong>the</strong>r elucidation of its<br />

pathology are needed.<br />

Disclosure: All authors have declared no conflicts of interest.<br />

1587P SARCOPENIA AFFECTS TREATMENT TOXICITY IN<br />

METASTATIC COLORECTAL CANCER PATIENTS: RESULTS<br />

OF A PROSPECTIVE MULTICENTER STUDY<br />

M. Barret 1 , C. Dalban 2 , J. Taieb 3 , D. Malka 4 , T. Mansourbakht 5 ,E.Latko 6 and<br />

S. Antoun 7<br />

1 Gastroenterology, Hopital Européen Georges Pompidou, Paris, FRANCE,<br />

2 Department of Biostatistics and Epidemiology (ea4184), Centre Georges<br />

François Leclerc, Dijon, FRANCE, 3 Gastroenterology and Digestive Oncology,<br />

Hopital Européen Georges Pompidou, Paris, FRANCE, 4 Oncology, Institut<br />

Gustave Roussy, Villejuif, FRANCE, 5 Gastroenterology, Hopital de la Pitié<br />

Salpetriere, Paris, FRANCE, 6 Nutricia Advanced Nutrition, Danone, St Ouen,<br />

FRANCE, 7 Emergency Department, Institut Gustave Roussy, Villejuif, FRANCE<br />

Background: Malnutrition reduces tolerance to treatment, quality of life, and survival<br />

in numerous cancers, including metastatic colorectal cancer (mCRC). Previous<br />

Volume 23 | Supplement 9 | September <strong>2012</strong> doi:10.1093/annonc/mds416 | ix511

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